Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
J Ocul Pharmacol Ther. 2011 Aug;27(4):333-7. doi: 10.1089/jop.2011.0001. Epub 2011 Jun 24.
To compare the tolerability of preserved diclofenac sodium 0.1% (Voltaren Ophtha) and preservative-free diclofenac (Dicloftil).
Thirty healthy volunteers received a single drop of Voltaren Ophtha in 1 eye, and a single drop of Dicloftil in the other. Both drops were instilled at the same time, in a single-blind manner. Visual analog scale grading was used to measure ocular discomfort, itch, burn, and pain. Grading was obtained before drop instillation and after 15 s, 1 min, 5 min, 15 min, and 30 min.
Both preparations caused discomfort, itch, burn, and pain, with a peak effect on all 4 parameters at 15 min. However, preservative-free Dicloftil proved to be more tolerable than preserved Voltaren Ophtha. Data show significantly lower reported levels of discomfort and itch up to 15 min, lower levels of burn at the first minute, and less pain immediately after instillation.
This is the first study to compare subjective ocular tolerability of a single drop. Our results indicate that Dicloftil has better tolerability than Voltaren Ophtha. Ophthalmologists should be aware of this significant difference when prescribing diclofenac, especially in patients with low compliance or who require prolonged therapy.
比较含防腐剂的 0.1%双氯芬酸钠（Voltaren Ophtha）和不含防腐剂的双氯芬酸（Dicloftil）的耐受性。
30 名健康志愿者同时接受单滴 Voltaren Ophtha 滴入 1 只眼，以及单滴 Dicloftil 滴入另 1 只眼。采用单盲法进行。使用视觉模拟量表评分来衡量眼部不适、瘙痒、烧灼感和疼痛。在滴注前和滴注后 15s、1min、5min、15min 和 30min 进行评分。
两种制剂均引起不适、瘙痒、烧灼感和疼痛，所有 4 个参数在 15min 时达到高峰效应。然而，不含防腐剂的 Dicloftil 比含防腐剂的 Voltaren Ophtha 更耐受。数据显示，在 15min 内报告的不适和瘙痒程度显著降低，在第 1 分钟时烧灼感程度较低，滴注后即刻疼痛程度较轻。
这是第一项比较单滴眼部耐受性的研究。我们的结果表明，Dicloftil 比 Voltaren Ophtha 具有更好的耐受性。眼科医生在开处方时应注意到这种显著差异，特别是在低依从性或需要长期治疗的患者中。
